BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P930022 · Supplement: S001 · Decision Mar 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    LEGEND PLUS PACEMAKER FAMILY
    PMA Number
    P930022
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    DXY
    Generic Name
    implantable pacemaker Pulse-generator
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 13, 2002
    Date Received
    February 27, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROGRAMMER SOFTWARE FOR THE MARQUIS DR ICD, MODEL 9896 CARELINK PROGRAMMER SOFTWARE FOR THE JEWEL (MODEL 7218), AND VITATRON MODEL VSC02 VERSION 6.1 CARELINK PROGRAMMER SOFTWARE. IN ADDITION, THIS SUBMISSION INCLUDES THE FOLLOWING PROGRAMMER SOFTWARE APPLICATIONS (PREVIOUSLY APPROVED FOR OTHER MEDTRONIC, VITATRON, OR CPI PROGRAMMERS) THAT HAVE BEEN MODIFIED FOR USE WITH THE MODEL 2090 CARELINK PROGRAMMER: VITATRON PROVIT MODEL VSA02 V6.1, KAPPA 400 (9952/A), KAPPA 600/700 (9953/A), KAPPA 800/900 (9988), SIGMA (9963/A), INSYNC (9980), REVEAL PLUS (9809), ANALYZER (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), BASELINE 7 (9891/A), CPI PRELUDE (9892), CPI TRIUMPH (9892), JEWEL PCD (9895), JEWEL CD (9895), JEWEL AF (9961), JEWEL PLUS (9895), PCD (9895), PREVA D, ST-DR (9959, JEWEL (9894), JEWEL II (9955). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/ VITATRON CARELINK PROGRAMMER MODEL 2090 AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXY Implantable Pacemaker Pulse-Generator